Atovaquone

Product NDC
50268-086
11-digit product format
502680086
Labeler code
50268
Product ID
50268-086_10fc4532-0b9f-4511-b0a2-bd7edd49cb47
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atovaquone
Dosage form
SUSPENSION
Route
ORAL
Labeler
AvPAK
Application
ANDA210692
Marketing category
ANDA
Marketing start
2020-05-07
Marketing end
0000-00-00
Substance
ATOVAQUONE
Active strength
750 mg/5mL
Pharmacologic classes
Antimalarial [EPC], Antiprotozoal [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-086-11ML - Milliliter50268-0869970e297-9208-456f-b579-e8336667466012020-06-05
50268-086-12ML - Milliliter50268-0866fd99c2c-c200-4fa4-a364-7df1d698e20a12020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-086ATOVAQUONE SUSPENSION [AVPAK]3Legacy NDC20240110_a50fb7df-6f2d-63f9-e053-2a95a90ad9d3.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50268-086-125026800861220 CUP, UNIT-DOSE in 1 BOX (50268-086-12) > 5 mL in 1 CUP, UNIT-DOSE (50268-086-11) 2020-05-070000-00-00NoNoCurrent